Aqueous Vascular Endothelial Growth Factor (VEGF) Levels in Type 3 Neovascularization

May 6, 2011 updated by: University of Molise

Aqueous Humor Levels of Vascular Endothelial Growth Factor Before and After Intravitreal Bevacizumab in Type 3 Versus Type 1 and 2 Neovascularization. A Prospective, Case-control Study.

This is a pilot, prospective, interventional, case-control study investigating aqueous levels of vascular endothelial growth factor (VEGF) in eyes with AMD-related neovascularization treated with intravitreal bevacizumab at the Medical Retina Department, University of Molise, Campobasso.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a pilot, prospective, interventional, case-control study investigating aqueous levels of VEGF in eyes with AMD-related NV treated with intravitreal bevacizumab.

Classification of neovascularization was based on its anatomic localization as ascertained by multimodal imaging employing FA (fluorescein angiography), ICGA (indocyanine green angiography) and OCT (optical coherence tomography) as recently proposed by Freund et al.

Diagnostic procedures and follow-up At baseline all the patients underwent BCVA measurement using early treatment diabetic retinopathy study (ETDRS) chart at 4 meters, fundus biomicroscopy, FA, ICGA and sd-OCT. All examinations were repeated in occasion of the follow-up appointments with exception of angiographic tests.

Angiographic tests and OCTs scans were recorded using Spectralis sd-OCT (Spectralis SD-OCT, Heidelberg Engineering, Heidelberg, Germany).

CMT was calculated after acquiring a sequence of 145 horizontal sections recorded in the high-resolution mode (1024 A-scans/30 degrees) and covering an area of 20 degrees (horizontal) × 15 degrees (vertical) with a distance of ~30 µm between individual sections. On follow-up examinations, the imaging processing software allowed reevaluation at exactly the same location.

The images were then processed by the "Thickness Map" analysis program. Field 1 of the map analysis protocol (central 1 mm) was used for central retinal thickness calculations.

Aqueous Sampling and Bevacizumab Injections All patients with AMD-related neovascularization received three intravitreal injections of 1.25 mg/0.05 ml of bevacizumab (Avastin; Genentech Inc, South San Francisco, California, USA) at baseline, month 1 and month 2.

Before injection, topical anesthesia was induced by tetracaine (1%) eye drops. Povidone-iodine was applied to the eyelid margins, the lashes, the conjunctiva bulbi and the fornices. After application of a sterile drape, a lid speculum was inserted.

Immediately before each intravitreal injection, aqueous sampling was performed by aspirating 0.05-0.1 ml of aqueous using a 30-gauge needle connected to a tuberculin syringe at the temporal limbus. All the samples were collected in the operating theatre under operating microscope control.

Intravitreal bevacizumab (IVB) injection was then performed using a 30-gauge needle in the inferotemporal quadrant at 3.5 mm to 4 mm posterior to the limbus.

The undiluted aqueous samples were transferred into sterile containers and immediately stored in a -80°C freezer until analysis.

Control Group Reference samples were obtained from 14 age-matched patients undergoing cataract surgery.

Aqueous humor samples were obtained in the same fashion described above for eyes with wet-AMD. The undiluted aqueous samples were transferred into sterile containers and immediately stored in a -80°C freezer until analysis.

Vascular Endothelial Growth Factor Assay Collected samples were gradually equilibrated to room temperature before beginning the assay and diluted 1:1 with the sample diluent provided by the manufacturer.

The VEGF content was determined on 50 µl of diluted sample with a human VEGF ELISA kit (EHVEGF, Pierce Biotechnology, Rockford, Illinois, USA) according to the manufacturer's instruction and using an extended standard curve including a 16, 8 and 4 pg/ml standard point. All assays were performed in duplicate. The minimum detectable concentration of VEGF was 3.5 pg/ml. Values inferior to 3.5pg/ml were considered equal to 1 for statistical analysis.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Campobasso, Italy, 86100
        • University of Molise

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • wet age-related macular degeneration type 1, 2 or 3

Exclusion Criteria:

  • BCVA at baseline less than 1.0 logMAR
  • any previous treatment of the neovascular lesion
  • previous vitrectomy
  • laser coagulation within the last 3 months
  • previous participation in any studies using investigational drugs within 3months preceding day 0
  • intraocular surgery (including cataract surgery) in the study eye within 3 months preceding day 0
  • glaucoma in the study eye; diabetes mellitus
  • use of immunosuppressive drugs
  • malignant tumors of any location

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Type 3 NV
Wet-AMD related type 3 neovascularization
Procedure: Aqueous sample
Aqueous sample (0.1ml of aqueous)+ intravitreal injection of bevacizumab (1.25mg/0.05ml)
Other Names:
  • Avastin
Procedure: Aqueous sample
Aqueous sample (0.1ml)+intravitreal injection of bevacizumab (1.25mg/0.05ml)
Other Names:
  • Avastin
Procedure: Aqueous sample
Aqueous sample (0.1ml)+ intravitreal injection of bevacizumab (1.25mg/0.05ml)
Other Names:
  • Avastin
Procedure: Aqueous sample
Aqueous sample (0.1ml)
Other Names:
  • Avastin
Active Comparator: Type 2 NV
Wet-AMD related type 2 neovascularization
Procedure: Aqueous sample
Aqueous sample (0.1ml of aqueous)+ intravitreal injection of bevacizumab (1.25mg/0.05ml)
Other Names:
  • Avastin
Procedure: Aqueous sample
Aqueous sample (0.1ml)+intravitreal injection of bevacizumab (1.25mg/0.05ml)
Other Names:
  • Avastin
Procedure: Aqueous sample
Aqueous sample (0.1ml)+ intravitreal injection of bevacizumab (1.25mg/0.05ml)
Other Names:
  • Avastin
Procedure: Aqueous sample
Aqueous sample (0.1ml)
Other Names:
  • Avastin
Active Comparator: Type 1 NV
Wet-AMD related type 1 neovascularization
Procedure: Aqueous sample
Aqueous sample (0.1ml of aqueous)+ intravitreal injection of bevacizumab (1.25mg/0.05ml)
Other Names:
  • Avastin
Procedure: Aqueous sample
Aqueous sample (0.1ml)+intravitreal injection of bevacizumab (1.25mg/0.05ml)
Other Names:
  • Avastin
Procedure: Aqueous sample
Aqueous sample (0.1ml)+ intravitreal injection of bevacizumab (1.25mg/0.05ml)
Other Names:
  • Avastin
Procedure: Aqueous sample
Aqueous sample (0.1ml)
Other Names:
  • Avastin
Other: Controls
Aqueous sample (0.1ml) in patients undergoing cataract extraction
Procedure: Aqueous sample
Aqueous sample (0.1ml of aqueous)+ intravitreal injection of bevacizumab (1.25mg/0.05ml)
Other Names:
  • Avastin
Procedure: Aqueous sample
Aqueous sample (0.1ml)+intravitreal injection of bevacizumab (1.25mg/0.05ml)
Other Names:
  • Avastin
Procedure: Aqueous sample
Aqueous sample (0.1ml)+ intravitreal injection of bevacizumab (1.25mg/0.05ml)
Other Names:
  • Avastin
Procedure: Aqueous sample
Aqueous sample (0.1ml)
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aqueous VEGF concentration
Time Frame: Change from baseline of VEGF concentration at month 1
To establish if different types of wet-AMD were associated to different concentrations of VEGF at baseline
Change from baseline of VEGF concentration at month 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Macular thickness assessment
Time Frame: Change from baseline of macular thickness at month 1
to compare central macular thickness before and after treatment respectively.
Change from baseline of macular thickness at month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Molise

Investigators

  • Principal Investigator: Roberto dell'Omo, MD, University of Molise
  • Study Director: Ciro Costagliola, Professor, University of Molise

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

May 2, 2011

First Submitted That Met QC Criteria

May 6, 2011

First Posted (Estimate)

May 9, 2011

Study Record Updates

Last Update Posted (Estimate)

May 9, 2011

Last Update Submitted That Met QC Criteria

May 6, 2011

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UM-O-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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